Smart Capsule for Automatic Adherence Monitoring

Status Completed

Clinical Trial Summary

In pharmacotherapy trials in drug-dependent populations, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010). However, methods commonly used to determine compliance may result in inaccurate measurement of adherence. It is therefore essential to develop measurement systems that not only accurately and objectively measure compliance, but can also have the potential to increase compliance in difficult to treat disorders such as addiction. In this study, we propose to assess the acceptability, tolerability, and efficacy of the ID-Cap System, a novel compliance measurement device, in a healthy population.

Clinical Trial Description

The primary objective of the clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap System in a healthy population.

Participation in the study takes 10 visits over a period of approximately five weeks. The first visit is a screening visit to determine if participants are eligible to participate. After inclusion into the study, participants will be randomized into one of three groups. Participants randomized to Group 1 will have compliance measured by patient reports, pill count, and riboflavin measurement. Participants randomized to Group 2 will have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the e-Tect reader. Participants randomized to Group 3 will also have compliance measured by patient reports, pill count, riboflavin measurement, and data collected by the ID-Cap reader. However, participants randomized to this group will also receive reminder calls and/or text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time.

After the initial screening visit, participants will present to the clinic twice weekly to complete self-reports of compliance, provide urine samples for riboflavin assessment, and be assessed for adverse effects.

They will also be asked to attend one follow-up visit to include abdominal x-ray in order to confirm passage of the capsules. ;

Study Design

Related Conditions & MeSH terms

Medication Adherence

Clinical Trial Details

NCT number	NCT02344238
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	June 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.